Center for Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Biostatistics and Research Support, Clinical Trial Methodology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
BMC Infect Dis. 2022 Feb 14;22(1):152. doi: 10.1186/s12879-022-07107-w.
Many studies support the protective effect of breastfeeding on respiratory tract infections. Although infant formulas have been developed to provide adequate nutritional solutions, many components in human milk contributing to the protection of newborns and aiding immune development still need to be identified. In this paper we present the methodology of the "Protecting against Respiratory tract lnfections through human Milk Analysis" (PRIMA) cohort, which is an observational, prospective and multi-centre birth cohort aiming to identify novel functions of components in human milk that are protective against respiratory tract infections and allergic diseases early in life.
For the PRIMA human milk cohort we aim to recruit 1000 mother-child pairs in the first month postpartum. At one week, one, three, and six months after birth, fresh human milk samples will be collected and processed. In order to identify protective components, the level of pathogen specific antibodies, T cell composition, Human milk oligosaccharides, as well as extracellular vesicles (EVs) will be analysed, in the milk samples in relation to clinical data which are collected using two-weekly parental questionnaires. The primary outcome of this study is the number of parent-reported medically attended respiratory infections. Secondary outcomes that will be measured are physician diagnosed (respiratory) infections and allergies during the first year of life.
The PRIMA human milk cohort will be a large prospective healthy birth cohort in which we will use an integrated, multidisciplinary approach to identify the longitudinal effect human milk components that play a role in preventing (respiratory) infections and allergies during the first year of life. Ultimately, we believe that this study will provide novel insights into immunomodulatory components in human milk. This may allow for optimizing formula feeding for all non-breastfed infants.
许多研究支持母乳喂养对呼吸道感染的保护作用。尽管已经开发出婴儿配方奶粉来提供充足的营养解决方案，但仍需要确定母乳中有助于保护新生儿和促进免疫发育的许多成分。在本文中，我们介绍了“通过母乳分析预防呼吸道感染”（PRIMA）队列的方法学，这是一项观察性、前瞻性和多中心的出生队列研究，旨在确定母乳中具有保护作用的新型成分的新功能，这些成分可预防呼吸道感染和过敏疾病在生命早期发生。
对于 PRIMA 母乳队列，我们计划在产后第一个月招募 1000 对母婴。在出生后一周、一个月、三个月和六个月，将收集并处理新鲜母乳样本。为了确定具有保护作用的成分，将分析母乳样本中的病原体特异性抗体水平、T 细胞组成、人乳寡糖以及细胞外囊泡（EVs），并将其与使用两周一次的父母问卷收集的临床数据相关联。该研究的主要结局是父母报告的需要医疗干预的呼吸道感染次数。将测量的次要结局是在生命的第一年中由医生诊断的（呼吸道）感染和过敏。
PRIMA 母乳队列将是一个大型前瞻性健康出生队列，我们将采用综合的多学科方法来确定在生命的第一年中发挥作用的母乳成分对预防（呼吸道）感染和过敏的纵向影响。最终，我们相信这项研究将为母乳中的免疫调节成分提供新的见解。这可能有助于优化所有非母乳喂养婴儿的配方奶喂养。
